U.S. FDA DESIGNATES FOR PRIORITY REVIEW EISAI’S SUPPLEMENTAL NEW DRUG APPLICATION FOR ANTIEPILEPTIC DRUG FYCOMPA® AS TREATMENT FOR PEDIATRIC PATIENTS WITH EPILEPSY
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") has announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Eisai‘s antiepileptic drug (AED) Fycompa® (perampanel). This application seeks approval for an indication expansion to cover pediatric patients with partial onset seizures and primary generalized tonic-clonic seizures (PGTC) seizures. Furthermore, Eisai has included a study in this sNDA requested by the FDA in a Pediatric Written Request, and therefore FDA has designated this application for Priority Review, which means the review period will be six months. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of September 28, 2018.
This sNDA was based on the interim results of a Phase III clinical study (Study 311) as well as the results from a Phase II clinical study (Study 232). Both studies suggested the safety and efficacy of adjunctive treatment with Fycompa was similar between pediatric patients and patients 12 years of age and older. The application aims to expand the indication for Fycompa in the United States, which currently covers monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older, to the age range down to 2 years of age. Based on data accumulated to date, the sNDA also seeks to expand the pediatric indication to include children 2 years of age and older for the adjunctive treatment of PGTC seizures.
Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. It is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. Fycompa has been approved in countries around the world including the United States as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) as well as PGTC seizures in patients with epilepsy 12 years of age and older. In the United States, Fycompa has also been approved as monotherapy for the treatment of partial-onset seizures (with or without secondarily generalized seizures). A new oral suspension formulation has also been approved and is available in the United States.
Epilepsy affects approximately 2.9 million people in the United States, 1 million people in Japan, 6 million people in Europe, and approximately 60 million people worldwide. While epilepsy affects people of all ages, incidence is particularly high among children and the elderly. As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs,1 this is a disease with significant unmet medical need.
Eisai considers neurology including epilepsy, a therapeutic area of focus, and strives to deliver Fycompa throughout the world in pursuit of our mission to provide "seizure freedom" to a greater number of patients living with epilepsy. Eisai seeks to further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.
Public Relations Department,
Eisai Co., Ltd.
[Notes to editors]
About Study 311
Study 311 is a global (United States, Europe, Japan, Asia) multicenter, open-label, single-arm trial with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of Fycompa oral suspension when administered as an adjunctive therapy in approximately 160 pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
Following the 23 week treatment phase in which patients were titrated to receive 2 to 16 mg of Fycompa orally once-daily, long term safety was assessed during an extension phase. In Japan, pediatric patients with partial-onset seizures were titrated to receive 2 to 12 mg of Fycompa orally once-daily. The adverse events (≥10% in the perampanel arms) observed in Study 311 at the time of interim analysis were somnolence, nasopharyngitis, dizziness, and irritability.
About Study 232
Study 232 was a global (United States, Europe), multicenter, open-label, long-term administration clinical study in approximately 63 pediatric patients with epilepsy (ages 2 to less than 12). The study evaluated the pharmacokinetics, safety, tolerability and efficacy of Fycompa oral suspension taken at the same time as other AEDs. Administration of once-daily Fycompa was titrated from 0.015 mg/kg to 0.18 mg/kg, and long-term safety was confirmed after 11 weeks of treatment and an extension phase (41 weeks). The most common adverse events (≥10% in the perampanel arms) observed in Study 232 were pyrexia, fatigue, vomiting, irritability, somnolence, dizziness, and upper respiratory tract infection.
1. "The Epilepsies and Seizures: Hope Through Research. What are the epilepsies?" National Institute of Neurological Disorders and Stroke, accessed May 24, 2016, http://www.ninds.nih.gov/disorders/epilepsy/detail_epilepsy.htm#230253109